FDA recall, , Moderate risk
GE MAC 5 Resting ECG Analysis Systems
Software in development was made available for customer use, which can associate clinical information with the incorrect patient.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems China Co., Ltd., of Wuxi, China, recalled its MAC 5 A4 Resting ECG Analysis System 855001-001 and MAC 5 A5 Resting ECG Analysis System 8855002-001.
The agency stated that software in development was inadvertently made available for customer use, and use of this software version can result in clinical information being associated with the incorrect patient, which could impact clinical decision-making. The company began the recall on April 21, 2026, and it was added to the FDA's Enforcement Report on June 3, 2026.
Distribution was worldwide, including US nationwide distribution in Florida and Georgia, and in India, Italy, Republic of Korea, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
- UDI-DI
- 00195278276070
- 00195278276124
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom.
- Company
- GE Medical Systems China Co., Ltd.Wuxi, China
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98917
- Recall number
- Z-2306-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
